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Atebimetinib

Phase 3

Pancreatic Cancer | Small molecule | Oncology |Immuneering Corporation|Last Updated: Jun 8, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment510
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07562152Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic AdenocarcinomaPHASE3 RECRUITING 510Jun 1, 2026Feb 1, 2029Jun 8, 202613 United States, Australia
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Study Endpoints
Primary Endpoints
Overall Survival
Up to approximately 2 years

The OS of participants with atebimetinib in combination with mGnP versus GnP

Secondary Endpoints
Progression Free Survival (PFS)
Up to approximately 2 years
Overall Response Rate (ORR)
Up to approximately 2 years
Disease Control Rate (DCR)
Up to approximately 2 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Atebimetinib + mGnPEXPERIMENTALAtebimetinib in combination with modified gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma
GnPACTIVE_COMPARATORStandard of care gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma
Interventions
NameTypeDescription
AtebimetinibDRUGOnce daily oral tablets
GnPDRUGStandard of care regimen for intravenous infusions of gemcitabine and nab-paclitaxel weekly for three weeks followed by one week without an infusion
mGnPDRUGBiweekly intravenous infusions of chemotherapy (gemcitabine and nab-paclitaxel)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Must be ≥18 years of age * Must have confirmed diagnosis according to AJCC staging as follows: * Metastatic pancreatic adenocarcinoma at least 12 weeks prior to screening * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Participants must be treatme...

Countries:United StatesAustralia
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Competitive Landscape -Pancreatic Cancer 186 trials
CompanyTickerTrialsLead PhaseDrugs
Revolution Medicines, Inc.RVMD9PHASE3RMC-6236, Gemcitabine, nab-paclitaxel, Irinotecan, Liposomal irinotecan
Arcus Biosciences, Inc.RCUS3PHASE3Quemliclustat, Nab-paclitaxel, Gemcitabine, Zimberelimab, Etrumadenant
AstraZeneca PLCAZN9PHASE2AZD0901, 5-Fluorouracil, Leucovorin, l-leucovorin, Irinotecan
AngioDynamics, Inc.ANGO2PHASE3Modified FOLFIRINOX Regimen
Pfizer Inc.PFE9PHASE2tisotumab vedotin, pembrolizumab, carboplatin, cisplatin, ponsegromab
AbbVie, Inc.ABBV4PHASE2TTX-030, nab-paclitaxel and gemcitabine, Nab-Paclitaxel and gemcitabine, Telisotuzumab adizutecan, Fluorouracil, Folinic acid/ Leucovorina
Bristol-Myers Squibb CompanyBMY4PHASE2Navlimetostat, Gemcitabine, Nab-paclitaxel, BMS-986340, BMS-936558-01
Immuneering Corp. Class AIMRX2PHASE3Atebimetinib, GnP, mGnP, IMM-1-104 Monotherapy
RenovoRx, Inc.RNXT1PHASE3Gemcitabine, nab-paclitaxel
BioNTech SE Sponsored ADRBNTX2PHASE2Pumitamig, Nab-paclitaxel, Gemcitabine, mFOLFIRINOX, Autogene cevumeran
Agenus Inc.AGEN5PHASE2Botensilimab, Gemcitabine, Nab-paclitaxel, AGEN1423, Balstilimab
Eli Lilly and CompanyLLY7PHASE1LY4101174, LY4066434., Cetuximab, Nab paclitaxel, Gemcitabine
Merck & Co., Inc.MRK2PHASE2Belzutifan, Sacituzumab tirumotecan, Fluorouracil, Leucovorin or levoleucovorin, Cisplatin
Veracyte, Inc.VCYT1PHASE3Tislelizumab
ArriVent BioPharma, Inc.AVBP3PHASE2JAB-21822, MRG007, JAB-3312
Exelixis, Inc.EXEL1PHASE2Zanzalintinib, Everolimus
HUTCHMED (China) Limited Sponsored ADRHCM1PHASE2Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine, Nab-paclitaxel Plus Gemcitabine, Surufatinib with Nab-paclitaxel, and Gemcitabine
ImmunityBio IncIBRX2PHASE2N-803, Aldoxorubicin, PD-L1 t-haNK, Nab-paclitaxel, Gemcitabine
Candel Therapeutics, Inc.CADL1PHASE2Aglatimagene besadenovec
Incyte CorporationINCY3PHASE2Ruxolitinib, Capecitabine, Regorafenib, Pemigatinib, Retifanlimab
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Recent Changes (Last 90 Days)
LOWJun 8, 2026NCT07562152lastUpdatePostDate: changed
LOWJun 8, 2026NCT07562152lastUpdatePostDate: changed
LOWJun 8, 2026NCT07562152lastUpdatePostDate: changed
LOWJun 4, 2026NCT07562152startDate: changed
LOWJun 4, 2026NCT07562152startDate: changed
LOWJun 4, 2026NCT07562152startDate: changed
LOWJun 4, 2026NCT07562152startDate: changed
LOWMay 26, 2026NCT07562152primaryCompletionDate: changed
LOWMay 24, 2026NCT07562152studyFirstPostDate: changed
LOWMay 21, 2026NCT07562152NEW_TRIAL: changed
LOWMay 21, 2026NCT07562152NEW_TRIAL: changed